CAREGIVER2, Caregiver's Health Assessment : Clinical and Biological Markers

NCT ID: NCT02521740

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-10-31

Brief Summary

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Providing care for a disabled elderly may represent a risk for the health of the caregiver. The objective of the study is to assess the impact of caregiving in terms of clinical and biological markers in relation to disability and cognitive impairment.

Detailed Description

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The investigators hypothesize that an accumulation of stressful events related to care giving may induce a stress response to the caregiver. This stress response can be measured by biological markers (inflammation, transcription and immunity) and also by clinical markers (frailty, physical performance, nutrition). This stress response can be influenced by the subjective burden of the caregiver and by the severity of the disease of the care receiver (Activity of daily life capabilities, cognitive function, behavioral disturbance).

Conditions

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Caregivers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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caregivers

someone who takes care and lives with a disabled elderly

Research questionnaires, blood sample

Intervention Type OTHER

assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

controls

someone who lives with an healthy elderly

Research questionnaires, blood sample

Intervention Type OTHER

assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

Interventions

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Research questionnaires, blood sample

assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* living with the care-receiver ( or with a healthy elderly for the controls)
* care-receiver dependent for at least one Activity of the daily living ( Katz index) or having cognitive disorder ( \>2 Global Deterioration Scale)

Exclusion Criteria

* institutionalised elderly
* inability to understand and speak french
* Acute disease within the past month
* Anti-inflammatory or immuno-suppressive treatment
* End-of-life care
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Liege

OTHER

Sponsor Role collaborator

University of Namur

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire UCLouvain Namur

OTHER

Sponsor Role lead

Responsible Party

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Professor Maximilien Gourdin

Directeur Médical adjoint aux missions universitaires

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie de Saint-Hubert, MD, PhD

Role: STUDY_CHAIR

CHUDinant-Godinne

Locations

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CHU Dinant-Godinne

Mont-Godinne, Yvoir, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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florence potier, MD

Role: CONTACT

0032/81 42 21 75

Marie de Saint-Hubert, MD, PhD

Role: CONTACT

Facility Contacts

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florence potier, MD

Role: primary

Other Identifiers

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1318184

Identifier Type: -

Identifier Source: org_study_id

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